SECURESLEEVE, INFANT
Received Jun 29, 2018
Report 2020362-2018-00048 · MDR key 7650078
Device
Generic name
Splint, Extremity, Non-inflatable, External, Non-sterile
Manufacturer
Posey Products LlcModel number
8168ICatalog number
8168I
Lot number
UNK
Product problems
- Material Integrity Problem
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT IS SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN BY MANUFACTURING AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. AT THIS TIME THERE IS NOT EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR SAFE AND EFFECTIVE USE OF THE DEVICE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. (B)(4). NO PRODUCT RETURNED AT THIS TIME.
Description of Event or Problem
CUSTOMER REPORTED WHILE IN USE WITH THE SECURE SLEEVE THE PATIENT WAS ABLE TO REMOVE A TUBE, POSSIBLY A NASOGASTRIC TUBE. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN.
Description of Event or Problem
SUPPLEMENTAL REQUIRED FOR ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE SHOWS NO OTHER COMPLAINT SIMILAR TO THE EVENT ALLEGED. AT THIS MOMENT, THIS APPEARS TO BE AN ISOLATED EVENT WITH NO PRODUCT NON-CONFORMITY FOUND. WITHOUT THE RETURN OF THE DEVICE REPORTED ISSUE COULD NOT BE CONFIRMED. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES "NEVER ALTER OR REPAIR THIS PRODUCT. ALWAYS INSPECT BEFORE EACH USE: CHECK FOR BROKEN STITCHES OR PARTS; TORN, CUT OR FRAYED MATERIAL; OR HOOK-AND-LOOP FASTENERS THAT DO NOT HOLD SECURELY. DO NOT USE SOILED OR DAMAGED PRODUCTS. DOING SO MAY RESULT IN SERIOUS INJURY OR DEATH. DISPOSE OF DAMAGED PRODUCTS PER FACILITY POLICY FOR BIO-HAZARDOUS MATERIAL. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. (B)(4).